1. Field of the Invention
The present invention relates to medical headgear fabrics and more particularly to a headgear for treatment of sleep apnea.
2. Description of the Related Art
Medical headgear for the treatment of respiratory conditions such as sleep apnea vary depending upon the nature and severity of the condition. In some conventional sleep apnea headgear designs, the headgear is fabricated of material having an intermediate rigidity, somewhere between pliable and bendable, whereby this rigidity is not “rigid” as defined by the Definitions set forth hereinafter. FIG. 1 shows an exploded view partial cross-section for one conventional sleep apnea headgear fabric 100, having three layers: (i) an outer nylon-LYCRA® layer 102; (ii) a breathable foam layer 104; and (iii) a skin-facing nylon-LYCRA® layer 106. The three layers 102, 104, 016 are flame laminated to form the three layer laminate shown (in exploded form) in FIG. 1.
Conventionally, headgear 100 is made by flame lamination. Flame lamination is a process used, typically in the textile industry, to permanently join fabrics and/or foam/neoprene to provide functionality for specific applications. More specifically, a polyurethane (PU) foam and two nylon/spandex blends form a three layer composite. The PU is fed into one side of the flame lamination machine at the same one of the fabrics is also fed in. The top surface of the foam is melted by direct flame contact to generate a tacky condition. The melted foam and fabric are then fed through a compression roller to squeeze the two materials together forcing the melted foam into the pores of the fabric. As it cools a bond is formed. This process is then repeated to bond the other fabric to the foam.
Thermoforming is a conventional process used to make laminate products, such as shoe insoles, but it is not believed to be conventionally used to make medical headgear fabrics and/or sleep apnea headgear fabrics.
U.S. Pat. No. 6,019,101 (“Cotner”) discloses a nasal mask for treatment of sleep apnea. The Cotner mask includes a strap made from an elastically compliant material and a plastically deformable nose clip. The deformable nose clip may be manufactured from thin aluminum.
U.S. Pat. No. 6,269,814 (“Blaszczykiewicz”) discloses a sleep apnea headgear including a chinstrap made from a stretchable, breathable, laminated neoprene substitute. The inner surface of the chinstrap is made from LYCRA® fabric. The outer surface of the chinstrap is made of UBL loop material.
U.S. Pat. No. 6,470,886 (“Jestrabek-Hart”) discloses a headgear for treating sleep apnea including two panels. Each panel includes the following layers: (i) a skin-facing layer of soft, flexible cloth, pleasant to the touch; (ii) a plastic layer (ear encircling region only); (iii) soft flexible foam layer; and (iv) cloth outside surface layer. Although it is not immediately clear, it appears that the cloth outside surface layer, layer (iv), may be either covered, partially covered and/or replaced by a layer of material made of hook-and-loop fastener fabric (specifically, the hook side). As shown in FIG. 5 of Jestrabek-Hart, the Jestrabek-Hart headgear fabric has foam on only one side of its plastic layer. This construction may allow the plastic layer to tear through the outer fabric. Also, this construction will have a low degree of softness on the side of the plastic layer that has no foam.
U.S. Pat. No. 6,805,117 (“Ho”) discloses a headgear including mesh-like panels(s) and a rear joint piece. The panels(s) are made from a nylon-LYCRA® blend. The rear joint piece is made from LYCRA® laminated foam or neoprene.
U.S. Pat. No. 7,047,972 (“Ging”) discloses a respiratory mask including yokes and straps. The straps are made of laminated fabric and foam. Ging discloses that one commercially available material is “Beath-O-Prene”™ manufactured by Accumed, Inc. USA. The yokes are attached to the straps and are made of somewhat rigid plastic, such as nylon or polypropylene. It is noted that the yokes of the Ging mask are attached to the outside of the straps and not embedded within the laminate structure of the strap itself. It is believed that the Ging fabric requires separate attachment mechanisms such as sewing or clamping to secure its embedded plastic. Also, Ging is directed to a mask, and not a headgear or a sleep apnea headgear.
US patent application 2006/0081250 (“Bordewick”) discloses a nasal mask includes a mask holder and a stabilizing band. The mask holder is made out of rigid or semi-rigid material, such as glass-filled nylon.
US patent application 2007/0181135 (“Baker”) discloses a headgear assembly to treat sleep apnea. The Baker assembly includes a crown strap and a chin strap. The chin strap and crown straps are made of a breathable, elastic foam material laminated on both sides with a soft, moisture-wicking fabric. The outside fabric includes LYCRA® spandex and an anti-microbial agent, such as silver.
Description Of the Related Art Section Disclaimer: To the extent that specific publications are discussed above in this Description of the Related Art Section, these discussions should not be taken as an admission that the discussed publications (for example, published patents) are prior art for patent law purposes. For example, some or all of the discussed publications may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific publications are discussed above in this Description of the Related Art Section, they are all hereby incorporated by reference into this document in their respective entirety(ies).